How to Prepare for Internal & External Laboratory Audits

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Description:

This course will examine the formal laboratory audit from the perspective of the laboratory being audited. By the end of this course you will be able to explain, the different approaches the auditor can follow during an audit, the things the auditor will be looking for during a typical laboratory audit, an overview of a strategy the laboratory can use to handle audits, what the laboratory can do to prepare for the audit, how to handle the progress of an audit, how to follow up after completion of an audit and what constitutes obstructing regulatory audits

Curriculum for this course:

Introduction

Overview	2 min 03 secs
Learning objectives	2 mins 20 secs
Who should take this course	1 min 23 secs
Module overview	2 min 10 secs

Module 1: Introduction to Audits

Overview	50 secs
Approaches to audits	1 min 34 secs
How audits are usually performed	1 min 50 secs
Strategy for handling formal audits	2 min 10 secs

Module 2: Permitting Photography, Video, Sound Recordings and Providing Documents

Overview	1 min 02 secs
The question on permitting photography, video and sound recordings	1 min 40 secs
Policy of the use of photography, video and sound recording during audits	2 min 41 secs
What documents should be shown to the inspectors	1 min 23 secs
Documents that should not be reviewed	1 min 52 secs
Review activity	3 mins

Module 3: What will the Auditor Inspect?

Overview	1 min 34 secs
Roles of staff directly involved in the audit	1 min 45 secs
What will the inspectors audit	2 min 20 secs
Review of laboratory investigations and deviations	1 min 45 secs
Study and testing plans	2 mins 23 secs
Sample management	1 min 45 secs
Reference standards	2 min 23 secs
Laboratory instrumentation	56 secs
Laboratory operations	1 min 35 secs

Module 4: Audit Preparation and Participation

Overview	43 secs
Maintaining audit readiness	1 min 54 secs
Commonly requested items	1 min 29 secs
Role of the audit coordinator	2 min 23 secs
The operations center	1 min 45 secs
During the audit – opening meeting	1 min 54 secs
Documentation	2 min 02 secs
Answering auditors questions	1 min 14 secs
Tour of the laboratory and facility	2 min 10 secs
Exit meeting	1 min 38 secs
Review activity	3 mins

Module 5: Audit Follow Up and Obstructing Regulatory Audits

Overview	1 min 23 secs
Audit follow-up	1 min 45 secs
Obstructing regulatory audits	2 min 23 secs
Acceptable explanations	1 min 56 secs
Key points moving forward	2 min 02 secs

Conclusion

Final Assessment

Certification

Revision History

Redesigned course with new Articulate Storyline player	V2.0
Added new Review Activities	V2.0
Added new final exam question to align with learning objectives	V2.0
Updated Glossary links	V2.0